[Ad hoc announcement pursuant to Art. 53 LR] Roche provides update on phase II/III SKYSCRAPER-06 study in metastatic non-squamous non-small cell lung cancer
04 July 2024 - 3:00PM
UK Regulatory
[Ad hoc announcement pursuant to Art. 53 LR] Roche provides update
on phase II/III SKYSCRAPER-06 study in metastatic non-squamous
non-small cell lung cancer
- SKYSCRAPER-06 evaluating
tiragolumab plus Tecentriq and chemotherapy did not meet the
primary endpoints of progression-free survival at primary analysis
and overall survival at first interim analysis
- The combination of
tiragolumab plus Tecentriq and chemotherapy showed reduced efficacy
compared to the comparator arm
- Safety was consistent with
previous studies, however we intend to halt the
trial due to reduced efficacy compared to the
comparator arm
Basel, 04 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today that the phase II/III SKYSCRAPER-06 study,
evaluating tiragolumab plus Tecentriq® (atezolizumab)
and chemotherapy versus pembrolizumab and chemotherapy as an
initial (first-line) treatment for people with previously
untreated, locally advanced unresectable or metastatic non-squamous
non-small cell lung cancer, did not meet its primary endpoints of
progression-free survival (PFS) at its primary analysis with a
hazard ratio (HR) of 1.27 [95% CI: 1.02,1.57] and overall survival
(OS) at its first interim analysis with a HR of 1.33 [95% CI: 1.02,
1.73], which was immature. The combination of tiragolumab plus
Tecentriq and chemotherapy showed reduced efficacy in both PFS and
OS compared to the comparator arm in the intent-to-treat
population, which includes the phase II and phase III cohorts. The
overall safety profile remains consistent with the safety profile
previously observed for the combination of tiragolumab plus
Tecentriq and chemotherapy, and no new or unexpected findings were
identified. Based on these results, patients and investigators will
be unblinded and we intend to halt the study. A communication will
be sent to the investigators and results will be shared with health
authorities and subsequently presented at an upcoming medical
meeting.
“These results are disappointing as it was our hope that this
combination might yield improved outcomes for people living with
metastatic non-squamous lung cancer,” said Levi Garraway, M.D.,
Ph.D., Chief Medical Officer and Head of Global Product
Development. “We are thankful to all of the patients and healthcare
professionals involved in the study, and we will leverage the
learnings to inform our scientific understanding of the anti-TIGIT
pathway and new avenues in cancer research.”
Ongoing phase III studies are investigating treatment settings
and indications distinct from SKYSCRAPER-06. Based on today’s
results, we will evaluate any relevant changes needed to the
ongoing tiragolumab programme.
About SKYSCRAPER-06 study
SKYSCRAPER-06 is a global phase II/III, randomised,
placebo-controlled and double-blinded study evaluating tiragolumab
plus Tecentriq® (atezolizumab) and chemotherapy as an
initial (first-line) treatment versus pembrolizumab and
chemotherapy in 542 people with non-squamous non- small cell lung
cancer. Primary endpoints are overall survival (OS) and
progression-free survival (PFS).
About tiragolumab
Tiragolumab is an investigational novel immune checkpoint inhibitor
with an intact Fc region. Tiragolumab selectively binds to TIGIT, a
novel inhibitory immune checkpoint which suppresses the immune
response to cancer. Based on preclinical research, tiragolumab is
thought to work as an immune amplifier with other cancer
immunotherapies such as Tecentriq® (atezolizumab). The TIGIT
pathway is distinct but complementary to the PD-L1/PD-1 pathway.
Dual blockade with tiragolumab and Tecentriq may help overcome
immune suppression and restore the immune response.
About Tecentriq®
(atezolizumab)
Tecentriq is a cancer immunotherapy approved for some of the most
aggressive and difficult-to-treat forms of cancer. Tecentriq was
the first cancer immunotherapy approved for the treatment of a
certain type of early-stage (adjuvant) non-small cell lung cancer
(NSCLC), small cell lung cancer (SCLC) and hepatocellular carcinoma
(HCC). Tecentriq is also approved in countries around the world,
either alone or in combination with targeted therapies and/or
chemotherapies, for various forms of metastatic NSCLC, certain
types of metastatic urothelial cancer (mUC), PD-L1-positive
metastatic triple-negative breast cancer (TNBC), BRAF V600
mutation-positive advanced melanoma and alveolar soft part sarcoma
(ASPS).
Tecentriq is a monoclonal antibody designed to bind with a
protein called programmed death ligand-1 (PD-L1), which is
expressed on tumour cells and tumour-infiltrating immune cells,
blocking its interactions with both PD-1 and B7.1 receptors. By
inhibiting PD-L1, Tecentriq may enable the activation of T-cells.
Tecentriq is a cancer immunotherapy that has the potential to be
used as a foundational combination partner with other
immunotherapies, targeted therapies and various chemotherapies
across a broad range of cancers.
In addition to intravenous infusion, Tecentriq has been approved
as a subcutaneous formulation in over 40 countries. The approved
indications for Tecentriq SC mirror those of Tecentriq
IV.
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first
industrial manufacturers of branded medicines, Roche has grown into
the world’s largest biotechnology company and the global leader in
in-vitro diagnostics. The company pursues scientific excellence to
discover and develop medicines and diagnostics for improving and
saving the lives of people around the world. We are a pioneer in
personalised healthcare and want to further transform how
healthcare is delivered to have an even greater impact. To provide
the best care for each person we partner with many stakeholders and
combine our strengths in Diagnostics and Pharma with data insights
from the clinical practice.
In recognising our endeavour to pursue a long-term perspective
in all we do, Roche has been named one of the most sustainable
companies in the pharmaceuticals industry by the Dow Jones
Sustainability Indices for the fifteenth consecutive year. This
distinction also reflects our efforts to improve access to
healthcare together with local partners in every country we
work.
Genentech, in the United States, is a wholly owned member of the
Roche Group. Roche is the majority shareholder in Chugai
Pharmaceutical, Japan.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected
by law.
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